BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    COSY Cervicothoracic Occipital Rod-Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025040·G73 Dry Bath Incubator

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996134811·LATERAL,12MM COBB DISSECTOR

    VIATRONIX V3D COLON

    FDA 510(k)
    FDA Class 2 ·Radiology

    DURABLUE STERILIZATION WRAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·August 23, 2011

    PRC AC5000

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code LLZ·July 16, 2008

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013

    BD ALARIS¿ LVP 20D 2SS CV

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 7, 2022

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024